País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 7.5ug (A/Michigan/45/2015, X-275); Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 7.5ug (A/Singapore/INFIMH-16-0019/2016, NIB-104); Influenza virus B/Brisbane/60/2008 - like strain 7.5ug (B/Brisbane/60/2008 (Victoria lineage)); Influenza virus B/Phuket/3073/2013 - like strain 7.5ug (B/Phuket/3073/2013 (Yamagata lineage))
sanofi-aventis new zealand limited
Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 7.5 µg (A/Michigan/45/2015, X-275)
30 mcg
Suspension for injection
Active: Influenza virus A/Michigan/45/2015 (H1N1) pdm09 - like strain 7.5ug (A/Michigan/45/2015, X-275) Influenza virus A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain 7.5ug (A/Singapore/INFIMH-16-0019/2016, NIB-104) Influenza virus B/Brisbane/60/2008 - like strain 7.5ug (B/Brisbane/60/2008 (Victoria lineage)) Influenza virus B/Phuket/3073/2013 - like strain 7.5ug (B/Phuket/3073/2013 (Yamagata lineage)) Excipient: Octoxinol 9 Phosphate Buffered Saline
Prescription
Sanofi Pasteur Inc
FluQuadri Junior is indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluQuadri Junior is indicated for use in children aged 6 months to 35 months inclusive.
Package - Contents - Shelf Life: Syringe, 0.25 mL in type I USP glass cylinder - 5 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.25 ml in type I USP glass cylinder - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2013-08-13
FLUQUADRI™ FLUQUADRI™ JUNIOR _Inactivated Quadrivalent Influenza Vaccine (Split Virion) Influenza Virus Haemagglutinin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This vaccine has been prescribed for you. Do not pass it on to others. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: • What FluQuadri/FluQuadri Junior are and what they are used for • Before you are given FluQuadri/FluQuadri Junior • How FluQuadri/FluQuadri Junior are given • Possible side effects • Storing FluQuadri/FluQuadri Junior • Further information WHAT FLUQUADRI/FLUQUADRI JUNIOR ARE AND WHAT THEY ARE USED FOR FluQuadri and FluQuadri Junior are vaccines. Vaccines are used to protect you against infectious diseases. FluQuadri and FluQuadri Junior are recommended to help protect you against influenza. FluQuadri may be administered to persons aged 36 months and older, especially who run an increased risk of influenza- associated complications. FluQuadri Junior is designed for use in children aged 6 to 35 months. Influenza (flu) is a disease caused by different types of virus. Influenza viruses can spread rapidly, especially in homes or institutions, where it can be very easy for someone to catch flu and spread the disease. The greatest risk of catching flu is during the cold months between May and October. Your doctor will be able to recommend the best time for you to be vaccinated. Flu is present every year, even when epidemics or outbreaks are not reported. The vaccine will only help to prevent flu if it is caused by one of the four strains of virus contained in the vaccine, or other strains closely related to them. FluQuadri/FluQuadri Junior will not prevent flu if you are incubating the disease before vaccination or Leia o documento completo
NEW ZEALAND DATA SHEET – FLUQUADRI / FLUQUADRI JUNIOR (INFLUENZA VIRUS HAEMAGGLUTININ) 1 NAME OF THE MEDICINE Inactivated Quadrivalent Influenza Vaccine (Split Virion) Influenza Virus Haemagglutinin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FluQuadri for intramuscular injection is an inactivated influenza virus vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octoxinol-9 (Triton ® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate- buffered isotonic sodium chloride solution. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation. It is formulated to contain the following four influenza strains recommended for the 2019 influenza season: • A/Michigan/45/2015 (H1N1) pdm09-like virus (A/Michigan/45/2015 X-275) • A/Switzerland/8060/2017 (H3N2)- like virus (A/Brisbane/1/2018 X-311 • B/Phuket/3073/2013-like virus (B/Phuket/3073/2013; Yamagata lineage) • B/Colorado/06/2017-like virus (B/Maryland/15/2016 BX-69A; Victoria lineage) FluQuadri contains 60 micrograms (µg) haemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 µg HA of each of the four strains. FluQuadri Junior contains 30 µg HA per 0.25 mL dose in the recommended ratio of 7.5 µg HA of each of the four strains. The type and amount of viral antigens contained in FluQuadri/FluQuadri Junior conform to the annual requirements of the Australian Influenza Vaccine Committee (AIVC) and the World Health Organization (WHO) recommendations for the season. The amounts of HA and other ingredients per dose of vaccine are listed in Table 1. Neither antibiotics nor preservative are used during manufactu Leia o documento completo